“Partnering with and educating policy makers on the wisdom of reassessing laws that slow drug development, stifle competition between pharmaceutical companies, and adversely affect the health of patients with cancer will be essential.”
An unprecedented increase in the number of therapies have been approved for marketing by the US Food and Drug Administration in the past 2–3 years, but this continues at immense costs, with hundreds of drugs failing in clinical trials. Bringing a single new therapy to the market is estimated to cost US$2·6 billion.
Several factors within the traditional drug discovery process contribute to this situation. One way to reduce late-stage clinical development expenses is through stringent milestone-setting metrics, ultimately discontinuing most projects early in their lifecycles when costs are relatively low, rather than carrying questionable projects forward and allowing costs to accumulate.
One important factor is the inefficient and incomplete transfer of knowledge and information between academia, industry, and clinical domains throughout the lifecycle of drug development projects.
Improved integration of academic science and industrial execution for projects that are prioritised by clinical need could vastly improve efficiencies within the system, yielding both improved validation of drug targets earlier at substantially reduced costs and more precise definition of patient responder subpopulations that would inform the design of clinical trials.
The proposed model will do more than simply decrease the cost of drug development. This science-driven drug discovery approach will also improve patient access to cures.